Treatment News

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA® (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. This approval offers a once-daily option as part of a regimen for this population and includes a "capsule sprinkle" administration method for patients who cannot swallow capsules or tablets. Detailed information about the "capsule sprinkle" method is provided in the 'Instructions for Use' at the end of the Patient Information section of the Package Insert.

Now that three single-tablet regimens are available for HIV treatment, competition for the "best" option is intense. In phase III trials comparing efavirenz/FTC/tenofovir (Atripla) and elvitegravir/cobicistat/FTC/tenofovir (Stribild), the two regimens were equally safe and efficacious at week 48 (JW AIDS Clinical Care Jul 9 2012). Longer-term results from one of these trials are now available. The study was sponsored by the maker of elvitegravir/cobicistat/FTC/tenofovir.

Researchers from The Children’s Hospital of Philadelphia and the Perelman School of Medicine at The University of Pennsylvania, along with colleagues at the Botswana-Baylor Children's Clinical Centre of Excellence conducted the first large-scale comparison of first-line treatments for HIV-positive children, finding that initial treatment with efavirenz was more effective than nevirapine in suppressing the virus in children ages 3 to 16. However, the less effective nevirapine is currently used much more often in countries with a high prevalence of HIV.

Long-term use of highly active antiretroviral therapies (HAART) does not appear to be associated with impaired heart function in children and adolescents in a study that sought to determine the cardiac effects of prolonged exposure to HAART on children infected with the human immunodeficiency virus (HIV), according to a report published Online First by JAMA Pediatrics, a JAMA Network publication.

Prior to contemporary antiretroviral therapies (ARTs), children infected with HIV were more likely to have heart failure.

Concentrations of protease inhibitors (PIs) rose significantly with age in a study of more than 2400 people in the United Kingdom. Concentrations of nonnucleoside reverse transcriptase inhibitors (NNRTIs) and certain clinical parameters did not vary significantly with age in this analysis.

As HIV-positive people age, changes in liver function and other variables that influence drug metabolism could affect antiretroviral concentrations. To assess possible antiretroviral level changes with age, researchers analyzed data from the Liverpool TDM (therapeutic drug monitoring) Registry and linked findings with the UK Collaborative HIV Cohort (CHIC) Study. The analysis included all drug levels for PIs and NNRTIs.

The study team analyzed 3589 TDM plasma samples from 2447 antiretroviral-treated people. Most samples came from people taking lopinavir (22.4%), efavirenz (18.5%), atazanavir (17.0%) or saquinavir (11.6%).

Gilead Sciences, Inc. today announced it is voluntarily recalling lot B120217A of Vistide® (cidofovir injection) to the user level due to the presence of particulate matter found in some vials of this lot.

Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into the patient, the size of the particles and the patient’s underlying medical condition, and can be severe. Gilead is not currently aware of any complaint attributable to the particles.

The commonly prescribed antiretroviral (ARV) tenofovir raises the risk of kidney dysfunction among people with HIV, but the adverse effect occurs mostly within the first two years after beginning the therapy and then tapers in the years following.  Furthermore, it appears that while tenofovir may increase the risk of renal damage, the actual effect in terms of a rise in cases of kidney disease may prove modest. Following on the heels of other research studies that have identified tenofovir’s adverse effects on the kidneys, Canadian researchers looked to establish the magnitude of the effect; they published their findings in the journal Clinical Infectious Diseases.  

The active ingredient in Viread (tenofovir disoproxil fumarate) and a component of Atripla (efavirenz/emtricitabine/tenofovir), tenofovir is currently prescribed to about half of all people with HIV taking antiretrovirals.

What's New in the Guidelines?

The following key changes were made to update the March 28, 2012, version of the guidelines.

Drug-Resistance Testing
In persons failing INSTI-based regimens, the panel now recommends that a genotypic assay for INSTI resistance should be performed to determine whether to include a drug from this class in subsequent regimens (AII). Previously, the Panel recommended that INSTI resistance testing should be considered (BIII) in this setting.